Kornimate/medical-research-clean huggingface dataset:
validity of turkish version of promis-29 measure

Conditions: Musculoskeletal Diseases

Summary: this study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to acıbadem maslak hospital orthopedics and traumatology department. demographic information (age, education level, occupation, marital status) will be obtained from the patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor, and they will be asked to fill in the promis 29 and sf-36 v2 questionnaires. the promis 29 questionnaire contains 4 questions from each of the seven contents of promis (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). from the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20. sf-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health). the turkish translation of the promis 29 questionnaire is presented in annex-2. the translation of the promis 29 questionnaire into turkish was made by northwestern university according to the facit translation method. its turkish translation was obtained from northwestern university by signing a license agreement for use in scientific research. participants will first be asked to sign the informed consent form electronically. promis 29 and sf-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform. the external validity of the promis 29 questionnaire will be evaluated by its correlation with the sf-36 v2, a similar general health profile questionnaire. to evaluate inter-rater test-retest reliability, both scales will be filled in by patients a second time between 7-14 days.


Eligibility criteria:
inclusion criteria: * being over the age of 18, * to be able to read and speak turkish, * to have a chronic musculoskeletal disease * volunteering to participate in the study exclusion criteria: * to have serious medical conditions or complications (such as vision or hearing impairments) that may affect the participant's ability to respond to study questionnaires
hemodynamic testing strategies to assess pulmonary hypertension in heart failure

Conditions: Heart Failure

Summary: the goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. the main question\[s\] it aims to answer are whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

Eligibility criteria:
inclusion criteria: * adults age 18 years or older * heart failure with reduced ejection fraction (\<40%) * referred for rhc at our centre for evaluation of candidacy for advanced hf therapies. exclusion criteria: severe valvular or complex congenital heart disease short-term mechanical circulatory support for progressive cardiogenic shock (e.g. extracorporeal membrane oxygenation) acute coronary syndrome or revascularization occurred within 7 days prior to the rhc. pregnant or breast-feeding known hypersensitivity to sodium nitroprusside advanced liver dysfunction reduced capacity or inability to provide informed consent
a study of silodosin 8 mg daily for the treatment of nocturia in men with benign prostatic hyperplasia

Conditions: Nocturia; Prostatic Hyperplasia

Summary: silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with bph

this will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. the following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, pittsburgh quality of sleep index, nocturia quality of life

Eligibility criteria:
inclusion criteria: * males in good general health and at least 50 years of age, with symptoms of moderate to severe bph and nocturia (\>=2 episodes per night) exclusion criteria: * medical conditions that would confound the efficacy evaluation. * medical conditions in which it would be unsafe to use an alpha-blocker. * the use of concomitant drugs that would confound the efficacy evaluation. * the use of concomitant drugs that would be unsafe with this alpha-blocker.

Keywords: nocturia bph benign prostate hyperplasia nocturia in men with benign prostate hyperplasia
usefulness of coronary computed tomography angiography for therapeutic decision- making; revascularization

Conditions: Coronary Artery Disease, Ischemic Heart Disease

Summary: as the prospective, observational, cross-sectional study, the accuracy of ct angiography-based therapeutic decision-making for revascularization will be evaluated. the primary objective of this study is to evaluate the accuracy of ct angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether ct angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.


Eligibility criteria:
inclusion criteria: * patients ≥ 20 years old * patients who are scheduled for elective conventional coronary angiography and are undergone ct angiography prior to conventional coronary angiography. exclusion criteria: * pregnant women or women with potential childbearing

Keywords: coronary ct angiography; revascularization; decision-making
apple cider vinegar for the prevention of urinary lithiasis (apul)

Conditions: Kidney Stones, Urolithiasis, Hypocitraturia

Summary: the purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. the study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. there will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

Eligibility criteria:
inclusion criteria: * male and female volunteers 18-65 years old exclusion criteria: * history of peptic ulcer disease or gastroparesis * pregnant females * history of chronic kidney disease * history of urolithiasis * currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document. * history of diabetes

Keywords: kidney stones, urolithiasis, hypocitraturia, apple cider vinegar
the european paediatric network for haemophilia management ( pednet registry)

Conditions: Factor VIII Deficiency; Factor IX Deficiency

Summary: rationale: haemophilia is a rare disease; to improve knowledge international collaboration is needed. well-defined clinical data will be collected from complete cohorts in order to prevent selection bias. objective: to collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

design: multicenter prospective observational birth cohort study population: patients with haemophilia a and b with fviii/ix levels of \<1 to 25% born between 1-1-2000 and 1-1-2030. intervention: no intervention; only documentation of patient characteristics and parameters of routine patient care and outcome main outcome parameters: outcome: clinically relevant inhibitor development, bleeding pattern and joint status on physical examination and imaging. determinants: baseline fviii/ix levels, measurement of inhibitory antibodies, family history, fviii/ix gene mutation, details on replacement therapy (according to each infusion for the first 50 treatment days, and annually thereafter) and surgeries. nature and extent of the burden and risks associated with participation, benefit and group relatedness: * no burden for the patients. well-defined clinical data will be collected from the medical files. participating in this registry will not change the number of visits to the clinic. all outcome parameters that are collected (including laboratory results) are part of routine clinical care. * direct benefit is not to be expected. however, the direct interaction between centres that treat patients with rare diseases improves both clinical care and will result in better guidelines and as such may provide indirect benefit. * multicentre participation: haemophilia is a very rare condition. therefore, collecting data on a multi-centre observational cohort is the only way to study this specific population. * the registry concerns young boys and girls with haemophilia and cannot be performed in older patients, as \>90% of inhibitors occur develop during the first 50 exposure days, and the results of prophylactic replacement therapy are highly dependent on the initiation of this treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with haemophilia a or b * factor viii/ ix activity of \<1 to 25% * complete records of factor treatment and bleeds * treated in one of the participating centres exclusion criteria: * patients referred because of an inhibitor\* * informed consent not obtained

Keywords: hemophilia children inhibitors prophylaxis long-term outcome congenital
long-term safety of lampalizumab intravitreal (itv) injections in participants with geographic atrophy (ga) secondary to age-related macular degeneration (omaspect)

Conditions: Geographic Atrophy

Summary: this multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with ga secondary to age-related macular degeneration (amd) who completed 96 weeks of treatment in studies gx29176 (nct02247479) or gx29185 (nct02247531). the extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. all participants will receive open-label lampalizumab in the present study.


Eligibility criteria:
inclusion criteria: * previous enrollment in studies gx29176 (nct02247479) or gx29185 (nct02247531) with completion of treatment and the week 96 visit * agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential exclusion criteria: * concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * increased risk of infection * pregnancy or lactation
ivabradine to treat microalbuminuria in patients with type 2 diabetes and coronary heart disease

Conditions: Diabetic Kidney Disease

Summary: to explore the efficacy of ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

this is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. patients with type 2 diabetes and coronary heart disease who are microalbuminuric \[urinary albumin excretion (uae): 30-500 mg/day\], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: group α: ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day. group β: placebo. urinary albumin excretion (uae) assessment will be performed before randomization (day 0), 28-day after randomization (day 28), and 90-day after randomization (day 28).

Eligibility criteria:
inclusion criteria: * 1. type 2 diabetes and coronary heart disease; * 2. urinary albumin excretion: 30-500mg/24h; * 3. sinus rhythm, and resting heart rate ≥ 70bpm; exclusion criteria: * 1. renal dysfunction defined as egfr \< 30ml/min/1.73m\^2; * 2. atrial flutter, and atrial fibrillation; * 3. resting heart rate \< 70bpm; * 4. combined with non-dihydropyridine ccb; * 5. uae\ 500mg/24h; * 6. acute heart failure; * 7. low blood pressure (bp\<90/50mmhg); * 8. acute myocardial infarction (\<14 days);
rc48 for neoadjuvant chemotherapy of her2 positive breast cancer

Conditions: Breast Cancer; HER2-positive Breast Cancer

Summary: this is a single-arm exploratory study to explore the effect of rc48 in her2-positive neoadjuvant therapy and evaluate the non-inferiority of rc48 by comparing the latest reported data of t-dm1 in neoadjuvant therapy.

a single-arm exploratory study was conducted in 20 patients with her2-positive breast cancer to explore the effect of rc48 in her2-positive neoadjuvant therapy (treatment regimen: rc482.0 mg/kg, intravenous drip, once every 2 weeks). after 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. the latest reported data of t-dm1 in neoadjuvant therapy were compared to evaluate the non-inferiority of rc48.

Eligibility criteria:
inclusion criteria: 1. enrolled were ≥ 18 years of age and \< 80 years of age 2. female or male breast cancer 3. patients with early or locally advanced breast cancer who are her2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: her2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive fish test. 4. left ventricular score ≥ 55% 5. ecogps score 0 or 1 6. able to understand the test requirements, willing and able to comply with the test and follow-up procedures 7. adequate organ function exclusion criteria: 1. cardiac, hepatic, renal, or psychiatric disease history 2. history of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
long-term follow-up studies at year 6, 7, 8, 9, 10: 2 formulations of combined hepatitis a/b vaccine compared in subjects aged 12-15 years

Conditions: Hepatitis B; Hepatitis A

Summary: to evaluate the persistence of anti-hepatitis a virus (anti-hav) and anti-hepatitis b surface antigen (anti-hbs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

open, randomized, long-term antibody persistence studies. immune persistence was compared between subjects who received one of the two formulations of glaxosmithkline biologicals' combined hepatitis a and hepatitis b vaccine according to a two-dose or three-dose schedule. these long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis a and b vaccine, to assess antibody persistence and a retrospective safety follow-up. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers vaccinated in study hab-084. * written informed consent obtained from the subject before the blood sampling visit of each year. exclusion criteria: • none

Keywords: hepatitis b twinrix™ adult hepatitis a twinrix™ junior
use of lumbar motion monitor to predict response to radiofrequency ablation after medial branch diagnostic blocks

Conditions: Back Pain

Summary: the study is being performed to determine if adding an objective measurement of back function can assess the success of a commonly performed back injection procedure-lumbar medial branch blocks. researchers also hope to compare whether those who have objective improvements after lumbar medial branch blocks will also have more successful lumbar medial branch radiofrequency ablation.

the current standard of care to determine the success of lumbar medical branch block(s) (mbb) is highly subjective, even if clinicians were to use validated questionairres. currently, there are no studies that use a validated objective functional outcome measure to practically and efficiently assess lumbar mbb success prior to radiofrequency ablation (rfa). the addition of a validated objective measure of functional impairment to the current standard of care may help us improve in identifying the patients that will benefit from lumbar rfa. it has the potential to minimize procedures of limited benefit with a significant impact on containing healthcare spending. additionally, it may further knowledge on how to appropriately select patients without relying on the stringent double block diagnostic technique put forth by the cms that may exclude patients who could greatly benefit from a lumbar rfa. as the objective measure the study will use a lumber motion monitor (lmm). the lmm weighs less than 5 pounds and fits on with a shoulder harness and belt. the lmm measures motion in all three directions (forward back, side to side, and twisting) just like the spine. the lmm testing may take up to 30 minutes depending on how many tasks can be performed by the participant and how many practice trials are required. the lmm testing includes bending forward and back to upright as fast as possible; comfortably while maintaining a twist position.

Eligibility criteria:
inclusion criteria: * male or female, 20 years of age to 70 years of age * capable and willing to consent * participants literate in english language * patients with predominately bilateral axial pain and clinical suspicion of lumbar facet pain. * patients who have completed conservative care: physical therapy (pt) exclusion criteria: * history of drug abuse/ dependency * history of prior lumbar medial branch block or medial branch radiofrequency ablation * changes to analgesic regimen in the last 30 days * allergy to lidocaine or bupivacaine local anesthetic * illiteracy (english) * presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia * predominately radicular pain. * patient reported limb pain greater than axial low back pain * previous lumbar spine surgery * any condition that the principle investigator may disqualify the patient * pregnancy
efficacy evaluation of the mushroom beverage on emotion regulation

Conditions: Inflammation, Brain; Emotional Problem

Summary: major depression disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. according to world health organization's report, it may be the first burden of disease in 2030. due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease. cordyceps militaris, one of the most treasure chinese herbs in asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. in winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. a previous study has demonstrated that cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.


Eligibility criteria:
inclusion criteria: 1. 21 -items hamilton rating scale for depression scores 8-17 points upon interview 2. at least 2 weeks not taking antidepressants, antipsychotics or antiepileptics. 3. understand the whole process of the study and had signed the informed consent form exclusion criteria: 1. had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period. 2. currently taking antidepressants or other medication that may impact the study. 3. expected to be non-adherent. 4. without sufficient data to confirm safety. 5. pregnant woman 6. allergic to fungal products. 7. currently taking mao-inhibitors
role and mechanisms of lipid and lipoprotein dysregulation in sepsis

Conditions: Sepsis; Shock, Septic

Summary: lipids and lipoproteins (cholesterol and lipid metabolites) are present in sepsis and are highly biologically active regulators of inflammation, but currently the changes in lipid and lipoprotein homeostasis during sepsis are not well understood. this project will investigate the changes in lipid and lipoprotein function, oxidation, metabolites, and changes in gene expression to further our understanding of dysregulated lipid and lipoprotein metabolism in sepsis. we will analyze a bank of samples and make associations with important clinical outcomes (early death, chronic critical illness and sepsis recidivism) as supported by our published work, and will confirm our findings in a small prospective cohort of sepsis patients.

this study will use biobanked samples from a diverse cohort of 165 sepsis patients (uf jacksonville and uf gainesville) and will confirm findings in a small prospective cohort of 50 patients. the following will be tested in patient samples: aim 1: test and compare hdl and ldl function (oxidation/transport) in sepsis patients by clinical outcomes of rapid recovery, early death, cci, and sepsis recidivism. aim 2: determine the changes in lipid homeostasis and patterns of inflammation that occur in sepsis patients by outcome. aim 3: characterize cholesterol \& lipoprotein-specific metabolic gene expression in whole blood leukocytes and peripheral blood mononuclear cells from sepsis patients.

Eligibility criteria:
inclusion criteria: * patients meeting the sepsis-3 definition of sepsis or septic shock * treatment with an institutional, evidence-based guideline management bundle for sepsis within 24 hrs of sepsis recognition * sequential organ failure assessment (sofa) score will be used for organ failure assessment. exclusion criteria: * a) alternative/confounding diagnosis causing shock (e.g., myocardial infarction or pulmonary embolus) * b) uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel) * c) advanced directives limiting resuscitative efforts * d) organ transplant recipient on immunosuppressive agents * e) known pregnancy * f) inability to obtain informed consent * g) hiv/aids with cd4 count \< 200, h) absolute neutrophil count \< 500. these criteria are justified by numerous prior studies.